eneboparatide (AZP-3601) / AstraZeneca - LARVOL DELTA

CALYPSO: Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism (clinicaltrials.gov) - P3 | N=165 | Active, not recruiting | Sponsor: Amolyt Pharma | Recruiting ➔ Active, not recruiting

Enrollment closed • Endocrine Disorders • Hypoparathyroidism • Renal Disease

Amolyt Pharma Enters into Definitive Agreement to be Acquired by AstraZeneca (GlobeNewswire) - "Amolyt Pharma...announced it has entered into a definitive agreement for AstraZeneca to acquire Amolyt Pharma at a purchase price of $800 million upfront and a potential milestone payment of $250 million....Under the terms of the agreement, AstraZeneca will acquire all of Amolyt Pharma’s outstanding shares for a total consideration of up to $1.05B, on a cash and debt free basis."

M&A • Acromegaly • Hypoparathyroidism

AZP-3601-CLI-001: AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism (clinicaltrials.gov) - P1/2 | N=132 | Completed | Sponsor: Amolyt Pharma | Phase classification: P1 ➔ P1/2

Phase classification • Endocrine Disorders • Hypoparathyroidism • Renal Disease

CALYPSO: Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism (clinicaltrials.gov) - P3 | N=165 | Recruiting | Sponsor: Amolyt Pharma

Trial completion date • Trial primary completion date • Endocrine Disorders • Hypoparathyroidism • Renal Disease

CALYPSO: Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism (clinicaltrials.gov) - P3 | N=165 | Recruiting | Sponsor: Amolyt Pharma | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Disorders • Hypoparathyroidism • Renal Disease • Solid Tumor

AZP-3601, a Novel PTH 1 Receptor Agonist, Induces Rapid Reduction and Normalization of Urinary Calcium in Chronic Hypoparathyroid Patients (ENDO 2023) - "Conclusion These data demonstrate that AZP-3601 treatment maintained sCa within the target range after withdrawal of conventional therapy likely acting via a potent effect on the tubular reabsorption of calcium. The observed significant improvement in both uCa and sP is expected to translate to a clinically meaningful benefit for cHP patients in the long-term."

Clinical • Endocrine Disorders • Hypoparathyroidism • Renal Disease

Treatment of Chronic Hypoparathyroidism with Eneboparatide (AZP-3601), a Novel PTH 1 Receptor Agonist: Results from a Phase 2 trial (ENDO 2023) - "Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"

P2 data • Endocrine Disorders • Hypoparathyroidism • Osteoporosis • Renal Disease • Rheumatology

AZP-3601, a Novel PTH 1 Receptor Agonist, Induces Rapid Reduction and Normalization of Urinary Calcium in Chronic Hypoparathyroid Patients (ENDO 2023) - "Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"

Clinical • Endocrine Disorders • Hypoparathyroidism • Renal Disease

CALYPSO: Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism (clinicaltrials.gov) - P3 | N=165 | Not yet recruiting | Sponsor: Amolyt Pharma

New P3 trial • Endocrine Disorders • Hypoparathyroidism • Renal Disease • Solid Tumor

AZP-3601-CLI-001: AZP-3601 SAD and MAD Study in Healthy Subjects and Subjects With Hypoparathyroidism (clinicaltrials.gov) - P1 | N=132 | Completed | Sponsor: Amolyt Pharma | Active, not recruiting ➔ Completed | Trial completion date: Jan 2023 ➔ Aug 2022 | Trial primary completion date: Dec 2022 ➔ Aug 2022

Trial completion • Trial completion date • Trial primary completion date • Endocrine Disorders • Hypoparathyroidism • Renal Disease

AZP-3601, a Long-Acting Parathyroid Hormone (PTH) Analog, Normalizes Blood Calcium in Thyroparathyroidectomized (TPTX) Rats Without Causing Deleterious Changes in Bone (ENDO 2022) - "With long-term (31 days) treatment and at doses that similarly normalized serum Ca ++ in TPTX rats, effects on bone were catabolic for PTH1-34 by continuous infusion, anabolic for PTH1-34 by daily injection, and neutral for AZP-3601 by daily injection. The distinct MOA used by AZP-3601 may thus result in less of an impact on bone than either daily injection or sustained, continuous delivery of PTH(1-34), when used as a long-term treatment for HP."

Preclinical • CNS Disorders • Cognitive Disorders • Endocrine Disorders • Epilepsy • Hypoparathyroidism • Orthopedics • Renal Disease

AZP-3601-CLI-001: AZP-3601 SAD and MAD Study in Healthy Subjects and Subjects With Hypoparathyroidism (clinicaltrials.gov) - P1 | N=130 | Active, not recruiting | Sponsor: Amolyt Pharma | Recruiting ➔ Active, not recruiting

Enrollment closed • Endocrine Disorders • Hypoparathyroidism • Renal Disease